PACKAGE LEAFLET: INFORMATION FOR THE USER …

1 1. WHAT azathioprine 50mg tablets ARE AND WHAT THEY ARE USED FORA zathioprine 50mg tablets contains the active substance azathioprine which belongs to a group of medicines called immunosuppressants. This means that they reduce the strength of your immune medicines are sometimes necessary to help your body accept an organ transplant, or to treat some diseases where your immune system is reacting against your own body (autoimmune diseases). azathioprine 50mg tablets are used to: Help your body accept a kidney, liver, heart, lung or pancreas transplant. [ azathioprine tablets are usually used together with other medicines in order to enhance their effect]. Treat severe rheumatoid arthritis Treat severe inflammation of the gut (Crohn s disease or ulcerative colitis) Treat some diseases where your immune system is reacting against your own body (autoimmune diseases) including severe inflammatory diseases of the skin, liver, arteries and some blood disorders.

2 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE azathioprine 50mg TABLETSDo not take azathioprine 50mg tablets : If you are allergic to azathioprine , 6-mercaptopurine or any of the other ingredients of this medicine (listed in section 6) If you have a severe infection If you have severe liver disease or severe bone marrow disease If you have an inflamed pancreas If you need or are going to have a vaccination containing a living virus or bacteria, such as BCG, smallpox or yellow fever vaccine If you are pregnant, unless your doctor thinks it is absolutely necessary (see Pregnancy, breast-feeding and fertility ) If you are breast-feeding (see Pregnancy, breast-feeding and fertility )Warnings and precautionsTalk to your doctor or pharmacist before taking azathioprine 50mg tablets : If you have or have ever had any liver or kidney problems If you have a condition where your body produces too little of a natural chemical called thiopurine methyltransferase (TPMT) If you have an infection for which you have not yet received treatment If you are pregnant or trying to become pregnant (see Pregnancy, breast-feeding and fertility ) If you are going to have an operation (this is because medicines including tubocurarine, pancuronium or succinylcholine used as muscle relaxants during operations may interact with azathioprine 50mg tablets ) If you have a rare genetic disorder called Lesch-Nyhan syndrome.

3 If you are receiving immunosuppressive therapy, taking Azathiprine 50mg tablets could put you at greater risk of:- tumours, including skin cancer. Therefore, when taking Azathiprine 50mg tablets , avoid excessive exposure to sunlight, wear protective clothing and use protective sunscreen with a high protection lymphoproloferative disorders treatment with Azathiprine 50mg tablets increases your risk of getting a type of cancer called lymphoproliferative disorder. With treatment regimen containing multiple immunosuppressants (including thiopurines), this may lead to death. A combination of multiple immonusuppressants, given concomitantly increases the risk of disorders of the lymph system due to viral infection (Epstein-Barr virus (EBV)-associated lymphoproliferative disorders).Taking Azathiprine 50mg tablets could put you at greater risk of: developing a serious condition called Macrophage Activation Syndrome (excessive activation of white blood cells associated with inflammation), which usually occurs in people who have certain types of should take care to avoid too much sun (including sunbeds) whilst taking azathioprine must use contraceptive methods whilst taking these tablets and for up to 3 months after you have finished taking them.

4 Suitable methods of contraception should be discussed with your doctor. Women using intra uterine devices (IUDs) should use additional contraceptive methods while taking azathioprine mutationIf you have an inherited mutation in the NUDT15-gene (a gene which is involved in the break-down of azathioprine 50mg tablets in the body), you have a higher risk of infections and hair loss and your doctor may in this case give you a lower medicines and azathioprine 50mg TabletsTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The following medicines may interact with azathioprine tablets : Allopurinol, oxipurinol or thiopurinol (used mainly to treat gout) Ciclosporin or tacrolimus (also used as immunosuppressant medicines) Infliximab (used to treat inflammation of the bowels [Crohn s disease]) Olsalazine, mesalazine or sulfasalazine (used mainly to treat ulcers or chronic inflammation of the colon and anal passage) Warfarin or phenprocoumon (used to prevent blood clots) ACE-inhibitors (used to treat high blood pressure and heart failure) Furosemide (used mainly to treat high blood pressure) Trimethoprim/sulfamethoxazole (used to treat bacterial infections) Cimetidine (used to treat stomach ulcers and indigestion) Indometacin (used as a painkiller and to treat inflammation) Cytotoxic medicines - also called chemotherapy (used to treat cancer) Vaccines (such as hepatitis B vaccine) Curare, d-tubocurarine, pancuronium or succinylcholine (used as muscle relaxants during operations).

5 You should inform your anaesthesiologist of your treatment with azathioprine 50mg tablets prior to , breast-feeding and fertilityAzathioprine 50mg tablets should only be taken if your doctor thinks it is absolutely necessary. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this of childbearing potential and men must use effective contraception during treatment with azathioprine and for at least 3 months after the treatment is discontinued. azathioprine has been reported to interfere with the effectiveness of intrauterine contraceptive devices (IUCD) therefore additional contraceptive measures are recommended. Do not take the tablets if you are and using machinesStudies on the effects of azathioprine on the ability to drive and use machines have not been performed. This product may cause dizziness, which could affect a patient s ability to HOW TO TAKE azathioprine 50mg TABLETSA lways take this medicine exactly as your doctor or pharmacist has told you.

6 Check with your doctor or pharmacist if you are not label on the carton will tell you how many tablets to take and when. The tablets should be swallowed whole with one full glass of water (about 200ml). Take your tablets during LEAFLET: INFORMATION FOR THE USERA zathioprine 50mg tablets AzathioprineRead all of this leaflet carefully before you start taking this medicine because it contains important INFORMATION for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What azathioprine 50mg tablets are and what it is used for 2. What you need to know before you take azathioprine 50mg Tablets3.

7 How to take azathioprine 50mg Tablets4. Possible side effects 5. How to store azathioprine 50mg Tablets6. Contents of the pack and other INFORMATION * Please note that only Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/dateProof ApprovalNon Printing ColoursColoursDate sent:Date received: Item no: Originator:Origination Date:Revision Date:Revised By:Dimensions:Min Body Text Size:Supplier:1. 2. 1. azathioprine 50mg tablets PIL - x 2979 doctor will monitor how you respond to your medicine and may change your dose if you are taking azathioprine 50mg tablets your doctor will want you to have a complete blood test performed, at least once a week, during the first 8 weeks of treatment. In certain situations, your doctor may decide to carry out blood tests more 8 weeks the frequency of the testing may be reduced and your doctor may ask you to repeat the complete blood test every month or at least at intervals of no longer than 3 organ transplantA dose of 5mg per kilogram of your bodyweight per day may be given on the 1st day of your treatment.

8 However, the usual maintenance dose is between 1 and 4mg per kilogram of your bodyweight per day. Your doctor may adjust this dose according to your body s response to your with chronic active hepatitisThe usual dose is between 1 and per kilogram of your bodyweight per conditionsThe usual starting dose is between 1 and 3mg per kilogram of your bodyweight per day. Your doctor will adjust the dose until it is right for in children and adolescentsWhere treatment is recommended, the dosage for children and adolescents is the same as the adult patients or patients with kidney or liver diseaseA smaller adult dose may be you have taken more azathioprine 50mg tablets than you shouldIn the event of overdose the most likely effect is bone marrow suppression reaching its maximum 9-19 days after dosing. You may get a sore throat, fever or infection. You may also feel tired or experience bruising and bleeding. If you have taken too many tablets , contact your doctor or go the nearest hospital casualty department immediately.

9 Remember to take the pack and any remaining tablets with you to show the you forget to take your azathioprine 50mg TabletsDo not take a double dose to make up for a forgotten tablet. Wait and take your next dose at the usual time. If you have missed more than one dose, contact your doctor for you stop taking azathioprine 50mg TabletsDo not stop taking your medicine unless the doctor tells you because stopping your medicine can make your condition your doctor does not see an improvement in your condition within three to six months, your doctor may wish to gradually reduce your dose and finally stop giving you this is important that you stop your treatment gradually. You should stop taking the tablets slowly, over a period of you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTSLike all medicines, this medicine can cause side effects, although not everybody gets should tell your doctor immediately if you: Get any ulcers in the throat, fever, bruises or bleeding, or you think you have an infection.

10 Experience any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting the whole body).The following side effects have been reported. Tell your doctor if any of these side effects become troublesome:Very common side effects (may affect more than 1 in 10 people) Infections (in kidney transplant patients) Reduction in number of white blood cells which makes infections more likely Feeling and being sick (nausea and vomiting) Loss of appetite (anorexia).Common side effects (may affect up to 1 in 10 people) Increased infections in patients with bowel inflammation Reduction in blood platelets which increases risk of bleeding or bruising Decrease in red blood cells in the blood (anaemia) Decrease in white blood cells in patients with rheumatoid arthritis Liver disease Certain types of cancer (lymphomas, cancer of the cervix, vulva and skin (especially on areas of the skin exposed to the sun)) are common in patients after kidney transplant Inflammation of the pancreas, which causes severe pain in the abdomen and backUncommon side effects (may affect up to 1 in 100 people)